AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: IZ01893 Exp. 2019-07-31; I801890 Exp. 2019-11-30
- 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:
- Tosoh Smd Inc
- Reason for Recall:
- The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle . In some cases, the quiet zone is too short and an error in barcode reading occurs. The problem is intermittent and not all vials (6 vials are available per set) have been reported to fail. The only risk to patients or users is a delay in results. The company recommends (optional) that customers pre-screen the vials to identify affected products. Customers can contact the company for reimbursement of any affected products. The company has implemented barcode checks as a temporary solution and will replace the barcode printer on the production line for products beginning with lot B*01898.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
Product Codes/Lot Numbers:
Lot Numbers: IZ01893 Exp. 2019-07-31; I801890 Exp. 2019-11-30
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0745-2020
Related Recalls
Power outages causes reporting software to shutdown.
Class I - Dangerous
Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.