AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for… — Class III medical device recall Z-0745-2020
Terminated recall by Tosoh Smd Inc, reported 2020-01-01, distributed nationwide. The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate
| Recall number | Z-0745-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Smd Inc, Grove City, OH, United States |
| Recall initiated | 2019-11-15 |
| Classified | 2019-12-26 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2020-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | EC |
| Quantity | 1,012 units |
| Lot numbers | I801890, IZ01893 |
| Model numbers | 020706 |
| Expiration dates | 2019-07-31, 2019-11-30 |
Product
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0745-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.