Recall Z-2827-2018 ยท JIX Calibrator, Multi-Analyte Mixture
Tosoh Bioscience Inc
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
| Date | Jun 5, 2018 |
| Status | Terminated |
| Reason | Distribution of unapproved product labeling |
| Root cause | Error in labeling |
| Action | The firm, Tosoh Bioscience, notified customers via a phone call on May 29, 2018 and May 31, 2018, reference "Product Labeling-Removal". The phone call described the product, problem and actions to be taken. The firm instructed to confirm receipt of the CD containing AAMs; return the unapproved labeling; if printouts were made of any information on the CD then destroy it, if not, thank customer for response and complete the Customer Call form. The firm will provide the Customers updated CD following approval and release. Any further questions, contact Sr. QA Manager at 614-317-1909 or email |
| Quantity | 9 CDS |
| Distribution | US Distribution to states of: FL, MA, MT, OK, OR and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 Tosoh Bioscience, Inc., Dec 1, 2011 |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET Tosoh Bioscience, Inc., Jun 15, 2012 |
| K981521 | AIA-PACK TPOAB ASSAY Tosoh Medics, Inc., Oct 8, 1998 |
| K981522 | AIA-PACK TGAB ASSAY Tosoh Medics, Inc., Oct 8, 1998 |