—#171957

Product

ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: LN 3P25-02; Lot 93284UIOO

Why it was recalled

Devices were delivered without the required dry ice.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On about 04/04/2019, Abbott notified customers in Latvia of the recall. Instructions included to examine inventory for any affected devices on hand, review the letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results, complete and return the Customer Reply form, and notify customers if the affected devices have been forwarded to other laboratories and provide them a copy of the notification letter. If replacement material is available, customers were instructed to discontinue the use of affected devices and destroy any remaining inventory according to your laboratory procedures. If replacement material is not available, immediately order replacement material. Abbott instructed customers that they may continue to use the impacted material as long as controls are within range. Destroy impacted material once replacement material is available.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Bldg Ap8b, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Distribution to Latvia.

Timeline

Recall initiated: 2019-04-09
Terminated: 2019-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171957. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.