Thyroglobulin Antibody recall
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of…
Why was Thyroglobulin Antibody recalled?
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
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?
Part Number 020391; Lot # B834868, Lot # BX34869, Lot # C234871, Lot # C434872 & Lot # C534873.
- Product
- Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of…
- Recalling firm
- Tosoh Bioscience Inc
- Quantity
- 34 boxess/2 sets/6 bottles
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
- Recall date
- March 17, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)