Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) 08P86-10, UDI/DI 05391523440745, Lot Numbers: 32004230, 35106210, 35810210, 36404220, 37209220; b) 08P86-19, UDI/DI 05391523441636, Lot Numbers: 35506210, 36010210, 36604220, 37409220
- 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:
- TECHNO-PATH MANUFACTURING LTD.
- Reason for Recall:
- Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
Product Codes/Lot Numbers:
a) 08P86-10, UDI/DI 05391523440745, Lot Numbers: 32004230, 35106210, 35810210, 36404220, 37209220; b) 08P86-19, UDI/DI 05391523441636, Lot Numbers: 35506210, 36010210, 36604220, 37409220
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0105-2024
Related Recalls
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
Multichem P, Part Code 08P90-10
TECHNO-PATH MANUFACTURING
Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.