FDA Device recall Z-0745-2020
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls
- FDA Device
- Class III
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class III recall of AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls by Tosoh Smd, citing 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 w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0745-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-11-15 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Tosoh Smd |
| Distribution | US |
Product
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
Reason
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.
Identifiers
| code_info | Lot Numbers: IZ01893 Exp. 2019-07-31; I801890 Exp. 2019-11-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0745-2020%22
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