Recall Z-0745-2020 ยท CDD Radioassay, Vitamin B12
Tosoh Smd Inc
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
| Date | Nov 15, 2019 |
| Status | Terminated |
| 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 resul |
| Root cause | Device Design |
| Action | Tosoh Bioscience issued Urgent Medical Device Correction on 11/15/19, letter states reason for recall, health risk and action to take: Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 14-days of receiving this notification by FAX, email, or postal mail as indicated on the form. In the event you receive Error Code 2220, discard the affected vial(s). You may pre-screen pretreatment 1 vials on AIA-2000 analyzers prior to reconstituting the vial to help identify vials that may return Error Code 2220. This is an optional pre-screen step and is not required f |
| Quantity | 1012 units |
| Distribution | Nationwide Foreign: Columbia, Dominic Republic, Ecuador |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964348 | AIA-PACK B12 ASSAY Tosoh Medics, Inc., Jan 13, 1997 |