Tosoh AIA-PACK B12 Pretreatment Set Recalled for Barcode Reading Errors
Tosoh Smd Inc is recalling AIA-PACK B12 Pretreatment Sets due to barcode scanning issues that may delay diagnostic results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source explicitly states the only risk is a delay in results, with no reported injuries or illnesses, fitting the criteria for cosmetic or documentation issues.
Plain-English summary
Tosoh Smd Inc is recalling 1,012 units of the AIA-PACK B12 Pretreatment Set, Part Number 020706. This in vitro diagnostic (IVD) product is used for the pre-treatment of calibrators and controls. The recall affects specific lots: IZ01893 (expiring July 31, 2019) and I801890 (expiring November 30, 2019). The products were distributed nationwide and in Colombia, the Dominican Republic, and Ecuador.
The recall is due to inadequate quiet zones on the barcodes, which can cause AIA-2000 bar code scanners to misread the symbols. This results in an error code (2220) and prevents the scanner from reading the barcode on the reagent bottle. The issue is intermittent and does not affect all vials in a set. The only identified risk to patients or users is a delay in diagnostic results.
Customers are recommended to pre-screen vials to identify affected products. Tosoh Smd Inc will reimburse customers for any affected products. The company has implemented temporary barcode checks and will replace the barcode printer on the production line for products beginning with lot B*01898.
The recalled product
- Product
- AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
- Manufacturer
- Tosoh Smd Inc
- Hazard
- Affected units
- 1,012
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers: IZ01893 Exp. 2019-07-31
- I801890 Exp. 2019-11-30
Distribution
Distributed nationwide across the United States.
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