VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 401006613389 401006613500 401006613501 401006613608 401006613609 401006613648 401006613671 401006613712 401006613796 401006613843 401006613890 401006584017 401006614028 401006584103 401006584161 401006584214 401006584259 401006584230 401006644380 401006644436 401006644502 401006644529 401006644574 401006584374 401006644604 401006644649 401006644670 401006644705 401006644745 401006644800 401006644871 401006644893 401006644896 401006664973 401006665040 401006665041 401006665223 401006665225 401006665226 401006665248 401006665295 401006665227 401006665228 401006665229 401006665306 401006675376 401006675473 401006675474 401006675513 401006675514 401006675559 401006675477 401006675478 401006675501 401006675552 401006675553 401006675630 401006675631 401006675659 401006675660 401006675803 401006695852 401006695862 401006695908 401006695916 401006675801 401006675802 401006695945 401006676062 401006676063 401006696041 401006696057 401006696079 401006696093 401006767884 401006767998 401006767999 401006768049 401006767969 401006768082 401006767882 401006768133 401006767904 401006767905 401006768134 401006768149 401006768150 401006768183 401006778247 401006778277 401006778340 401006778357 401006778358 401006778470 401006798465 401006798466 401006778505 401006778559 401006778575 401006778593 401006798664 401006798665 401006798696 401006798730 401006798697 401006798835 401006798855 401006798920 401006798997 401006798998 401006799028 401006799092 401006799093 401006799138 401006799171 401006799214 401006799195 401006819270 401006819319 401006819320 401006819370 401006819538 401006819552 401006839594 401006839663 401006839699 401006839700 401006839745 401006849830 401006849832 401006849911 401006849912 401006849947 401006840040 401006840092 401006870874 401006871010 401006871011 401006871101 401006871102 401006871103 401006871164 401006871165 401006871232 401006871233 401006901842 401006901882 401006901909 401006901996 401006901997 401006913185 401006913259 401006913330 401006955372 401006955417 401006955503 401006955526 401006955658 401006955598 401006955693 401006955694 401006975807 401006975882 401006975883 401007017794 401007017795 401007017810 401007017811 401006977863 401006977864 401007027860 401007027861 401007027926 401007027927 401007028173 401007028205 401007028206 401007028207 401007028242 401007028243 401007028284 401007028285 401007028286 401007028287 401007018345 401007018346 401007018411 401007018412 401007018413 401007081006 401007081007 401007081032 401007080873 401007080875 401007080930 401007080931 401007080932 401007080933 401007081055
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ortho-Clinical Diagnostics
- Reason for Recall:
- Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
Product Codes/Lot Numbers:
401006613389 401006613500 401006613501 401006613608 401006613609 401006613648 401006613671 401006613712 401006613796 401006613843 401006613890 401006584017 401006614028 401006584103 401006584161 401006584214 401006584259 401006584230 401006644380 401006644436 401006644502 401006644529 401006644574 401006584374 401006644604 401006644649 401006644670 401006644705 401006644745 401006644800 401006644871 401006644893 401006644896 401006664973 401006665040 401006665041 401006665223 401006665225 401006665226 401006665248 401006665295 401006665227 401006665228 401006665229 401006665306 401006675376 401006675473 401006675474 401006675513 401006675514 401006675559 401006675477 401006675478 401006675501 401006675552 401006675553 401006675630 401006675631 401006675659 401006675660 401006675803 401006695852 401006695862 401006695908 401006695916 401006675801 401006675802 401006695945 401006676062 401006676063 401006696041 401006696057 401006696079 401006696093 401006767884 401006767998 401006767999 401006768049 401006767969 401006768082 401006767882 401006768133 401006767904 401006767905 401006768134 401006768149 401006768150 401006768183 401006778247 401006778277 401006778340 401006778357 401006778358 401006778470 401006798465 401006798466 401006778505 401006778559 401006778575 401006778593 401006798664 401006798665 401006798696 401006798730 401006798697 401006798835 401006798855 401006798920 401006798997 401006798998 401006799028 401006799092 401006799093 401006799138 401006799171 401006799214 401006799195 401006819270 401006819319 401006819320 401006819370 401006819538 401006819552 401006839594 401006839663 401006839699 401006839700 401006839745 401006849830 401006849832 401006849911 401006849912 401006849947 401006840040 401006840092 401006870874 401006871010 401006871011 401006871101 401006871102 401006871103 401006871164 401006871165 401006871232 401006871233 401006901842 401006901882 401006901909 401006901996 401006901997 401006913185 401006913259 401006913330 401006955372 401006955417 401006955503 401006955526 401006955658 401006955598 401006955693 401006955694 401006975807 401006975882 401006975883 401007017794 401007017795 401007017810 401007017811 401006977863 401006977864 401007027860 401007027861 401007027926 401007027927 401007028173 401007028205 401007028206 401007028207 401007028242 401007028243 401007028284 401007028285 401007028286 401007028287 401007018345 401007018346 401007018411 401007018412 401007018413 401007081006 401007081007 401007081032 401007080873 401007080875 401007080930 401007080931 401007080932 401007080933 401007081055
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0267-2020
Related Recalls
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Ortho-Clinical Diagnostics
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
Ortho-Clinical Diagnostics
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Ortho-Clinical Diagnostics
Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.