Agency classClass IOur severity:Severe FDA (Devices)·Z-1932-2012·Announced 2012-07-18

Alere Triage D-dimer Kits Recalled for Decreased Precision

Alere San Diego is recalling 1,972 Triage D-dimer kits because certain lots may have decreased precision, potentially leading to false positive or negative results.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false…"

Plain-English summary

Alere San Diego, Inc. is recalling 1,972 Triage D-dimer kits (PN 98100) distributed nationwide. The product is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events, including pulmonary embolism.

The recall is due to a potential defect where certain lots may have significantly decreased precision relative to the package insert. This issue could result in an increased frequency of false positive or false negative results. These errors are unpredictable within lots and may not be detected by standard Quality Control testing.

The affected lots are identified by the following codes: Phase 1 includes W50069B, W50070B, W50071B, W50541B, W50551B, W50552B, and W50556B; Phase 2 includes W50550B. Healthcare providers and facilities should check their inventory for these specific lot codes and stop using the affected kits.

The recalled product

Product: Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Manufacturer: Alere San Diego, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: false-positive
false-negative
diagnostic-error
Affected units: 1,972

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)

Phase 1: W50069B
W50070B
W50071B
W50541B
W50551B
W50552B
and W50556B. Phase 2: W50550B

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Alere San Diego, 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 5 products in this recall →

Same manufacturer · Alere San Diego, Inc.

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