AIA-PACK TPOAb CONTROL SET
Reported: June 7, 2017 Initiated: February 8, 2017 #Z-2168-2017
Product Description
AIA-PACK TPOAb CONTROL SET
Reason for Recall
The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
Details
- Recalling Firm
- Tosoh Bioscience, Inc.
- Units Affected
- 15 boxes
- Distribution
- Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
- Location
- South San Francisco, CA
Frequently Asked Questions
What product was recalled? ▼
AIA-PACK TPOAb CONTROL SET. Recalled by Tosoh Bioscience, Inc.. Units affected: 15 boxes.
Why was this product recalled? ▼
The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 7, 2017. Severity: Low. Recall number: Z-2168-2017.
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