STA SYSTEM CONROL N + P (ref. 00678)
Reported: January 1, 2020 Initiated: November 18, 2019 #Z-0738-2020
Product Description
STA SYSTEM CONROL N + P (ref. 00678)
Reason for Recall
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Details
- Recalling Firm
- Diagnostica Stago, Inc.
- Units Affected
- 5,437
- Distribution
- US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
STA SYSTEM CONROL N + P (ref. 00678). Recalled by Diagnostica Stago, Inc.. Units affected: 5,437.
Why was this product recalled? ▼
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2020. Severity: Moderate. Recall number: Z-0738-2020.
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