Diagnostica Stago, Inc.: STA SYSTEM CONROL N + P (ref. 00678)

Is my product affected?

STA SYSTEM CONROL N + P (ref. 00678)

• UPC 03607450006780

Check against the official notice below — it lists the full affected range.

What happened

Diagnostica Stago, Inc. is recalling the STA SYSTEM CONTROL N + P (ref. 00678) due to a confirmed positive bias in the STA-Unicalibrator levels when used with STA-Deficient IX and STA-Deficient VIII products. The measurements from these products showed higher values compared to the International Standard for factor VIII or IX, and this bias was also detected in External Quality Assessment results. A total of 5,437 units were distributed across the United States in the following states: Massachusetts, Maine, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington D.C., Maryland, Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Mississippi, Kentucky, Ohio, Indiana, Michigan, Iowa, Wisconsin, Minnesota, South Dakota, North Dakota, Montana, Illinois, Missouri, Kansas, Louisiana, Arkansas, Oklahoma, Texas, Colorado, Arizona, Nevada, California, Hawaii, Oregon, Washington, and Alaska.

The affected product includes eight lot numbers: 253145, 253416, 253655, 254040, 254206, 254401, 254573, and 254760. The recall source does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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. 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 Quantity: 5,437 Lot/code info: REF: 00678 Lot Numbers: 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760 UDIs: (01)03607450006780(11)171130(17)191130(10)253145(241)00678 (01)03607450006780(11)180131(17)200131(10)253416(241)00678 (01)03607450006780(11)180331(17)200331(10)253655(241)00678 (01)03607450006780(11)180630(17)200630(10)254040(241)00678 (01)03607450006780(11)180731(17)200731(10)254206(241)00678 (01)03607450006780(11)180930(17)200930(10)254401(241)00678 (01)03607450006780(11)181031(17)201031(10)254573(241)00678 (01)03607450006780(11)181130(17)201130(10)254760(241)00678

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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