Diagnostica Stago, Inc.: STA UNICALIBRATOR (ref. 00675)

Is my product affected?

STA UNICALIBRATOR (ref. 00675)

• UPC 13607450006756

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

What happened

Diagnostica Stago, Inc. is recalling the STA UNICALIBRATOR (reference 00675) due to a confirmed positive bias in calibration levels for STA-Deficient IX and STA-Deficient VIII products when compared to the International Standard for factor VIII or IX. This same bias has been observed in several External Quality Assessment results. A total of 5,498 units across four lot numbers (253180, 253964, 254721, and 255108) have been distributed throughout the United States.

The recall affects medical facilities and laboratories across most U.S. states and territories, from Maine to Hawaii. The source document does not specify what actions affected consumers or healthcare providers should take regarding 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: 5,498 Lot/code info: REF: 00675 Lot Numbers: 253180, 253964, 254721, 255108 UDIs: (01)13607450006756(11)171231(17)191231(10)253180(241)00675 (01)13607450006756(11)180630(17)200630(10)253964(241)00675 (01)13607450006756(11)181130(17)201130(10)254721(241)00675 (01)13607450006756(11)190228(17)210228(10)255108(241)00675

Source

Official record: FDA (Device enforcement) ↗

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

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