Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0738-2020·Announced 2020-01-01

Diagnostica Stago Recalls STA System Control N + P Due to Positive Bias

Diagnostica Stago is recalling 5,437 units of STA System Control N + P because a positive bias was confirmed on specific calibrator levels.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a quality control issue without reported harm.

Plain-English summary

Diagnostica Stago, Inc. is recalling 5,437 units of STA System Control N + P (ref. 00678). The recall affects specific lot numbers: 253145, 253416, 253655, 254040, 254206, 254401, 254573, and 254760. The product was distributed in the United States, including states such as 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, and AK.

The recall was initiated because a positive bias was confirmed to exist 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. The source text notes that this bias is also observed on several External Quality Assessment (EQA) results.

The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of the product, nor does it report any illnesses or injuries associated with the use of the affected units.

The recalled product

Product: STA SYSTEM CONROL N + P (ref. 00678)
Manufacturer: Diagnostica Stago, Inc.
Category: Medical Device — Laboratory Reagent
Hazard: mis-calibration
Affected units: 5,437

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

REF: 00678 Lot Numbers: 253145
253416
253655
254040
254206
254401
254573

Distribution

Distributed in 42 states:

Part of a larger recall action

This product is one of 2 recalled by Diagnostica Stago, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Diagnostica Stago, Inc.

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Same hazard · mis calibration