Tosoh ST AIA-PACK HbA1c Calibrator recall
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the…
Why was Tosoh ST AIA-PACK HbA1c Calibrator recalled?
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots.
- Product
- Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the…
- Recalling firm
- Tosoh Bioscience Inc
- Quantity
- 1485
- Distribution
- USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
- Recall date
- May 23, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)