Recall Z-0588-2017 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Alere San Diego, Inc.
Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should
| Date | Nov 16, 2016 (initiated Oct 12, 2016) |
| Status | Terminated |
| Reason | Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card. |
| Root cause | Employee error |
| Action | The firm, Alere, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 10/2016 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of and discard the CODE Chip contained within the Alere Triage Total 5 Control Level 1 PN 88753 Lot C3233A; install the replacement QC Sample CODE Chip for Lot C3233AR; share this information with your laboratory staff and retain this notification as part of your laboratory QS documentation; if you have forwarded the product to another laboratory, provide copy of this notification; and |
| Quantity | 513 kits |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 Biosite Incorporated, Dec 7, 2007 |