Instructions for Use recall
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package…
Why was Instructions for Use recalled?
Instructions For Use had incorrect lot number and calibrator values
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?
Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)
- Product
- Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package…
- Recalling firm
- Tosoh Bioscience, Inc.
- Quantity
- 41 single sets of Progesterone 3 calibrators
- Distribution
- US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
- Recall date
- August 3, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)