Diagnostica Stago, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0737-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

STA UNICALIBRATOR (ref. 00675)

Product Classification:

Class II

Date Initiated: November 18, 2019

Date Posted: January 1, 2020

Recall Number: Z-0737-2020

Event ID: 84402

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.

Status: Terminated

Product Quantity: 5,498

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated