Tosoh recalls AIA-PACK B12 Pretreatment Sets for diagnostic use due to potential barcode reading errors that may delay test results. Affected products include specific lot numbers with expiration dates.
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.
Tosoh is recalling AIA-PACK B12 Pretreatment Sets used in diagnostic testing because some barcode scanners might misread the barcodes, causing delays in test results. The issue is intermittent and only affects a small number of vials in each set.
The barcode scanners in these sets rely on a quiet zone to correctly read barcodes. If the quiet zone is too short, the scanner may confuse barcodes with text or graphics, leading to errors like 'Unable to read barcode on reagent bottle' (Error Code 2220). This can cause delays in test results but does not pose a direct safety risk to users.
Users of diagnostic testing equipment who have the AIA-PACK B12 Pretreatment Set with specific lot numbers are affected. Laboratory staff and healthcare providers using these sets for calibrators/controls are most at risk.
Check the lot number on the product label: IZ01893 (expires July 2019) or I801890 (expires November 2019). The product is a Pretreatment Set for diagnostic use with part number 020706.
Look for lot numbers IZ01893 (expires July 2019) or I801890 (expires November 2019) on the product label.
If you have an affected product, contact Tosoh Smd Inc for reimbursement of the affected items.
The recall is due to potential barcode reading errors that may cause delays in test results. The issue is intermittent and only affects a small number of vials in each set.
Check the lot number on the product label: IZ01893 (expires July 2019) or I801890 (expires November 2019). The product is a Pretreatment Set for diagnostic use with part number 020706.
No, the recall states there is no risk to patients or users beyond potential delays in test results. The issue does not cause physical harm.
We’ve drafted a message you can send Tosoh to request your refund or repair — edit it as you like.
Subject: Recall Z-0745-2020 — Tosoh Tosoh Hello, I own a Tosoh that is covered by recall Z-0745-2020 from Tosoh. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
