Reported Jan 1, 2020 · Terminated
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
Tosoh Smd Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tosoh Smd Inc · 3600 Gantz Rd · Grove City, OH · 43123-1895
Is this the product you have?
- AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls
- Part Number020706
- Lot codes and dates
- Lot Numbers
IZ01893 Exp. 2019-07-31I801890 Exp. 2019-11-30
- Lot Numbers
- Amount recalled
- 1012 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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