Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.
Class I - DangerousWhat Should You Do?
- Check if you have this product: n/a
- 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:
- Roche Diagnostics Corporation
- Reason for Recall:
- New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.
Product Codes/Lot Numbers:
n/a
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1147-2019
Related Recalls
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Roche Diagnostics
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Roche Diagnostics
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.