Recall Z-0082-2007 ยท JIS Calibrator, Primary
Tosoh Bioscience Inc
TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box.
| Date | Oct 28, 2006 (initiated Sep 1, 2006) |
| Status | Terminated |
| Reason | Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument |
| Root cause | Other |
| Action | The firm mailed Urgent: Medical Device Recall letters to their customer accounts on 9/5/2006. The letter informs the customers of the calibration problem and asks that the customers examine their inventories for the presence of the suspect product and place any product found in quarantine. The letter also asks that the customers identify their subaccount/customers and notify them of the recall with a copy of the recall letter, if the product has been further distributed. The recall letter is accompanied by a Response form which the customer is asked to complete and return to TOSOH as soon a |
| Quantity | 151 boxes |
| Distribution | Nationwide distribution ---- including states of AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TX, WA, WI, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992365 | AIA-PACK FOLATE ASSAY Tosoh Medics, Inc., Aug 10, 1999 |