Agency classClass IOur severity:Severe FDA (Devices)·Z-1929-2012·Announced 2012-07-18

Alere Triage Cardiac Panel Recalled for Decreased Precision

Alere San Diego, Inc. is recalling 6,044 kits of the Alere Triage Cardiac Panel due to decreased precision that may cause 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 6,044 kits of the Alere Triage Cardiac Panel (PN 97000HS). This medical device is used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin, and troponin I in EDTA anticoagulated whole blood or plasma specimens.

The recall was initiated because certain lots of the affected products 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 Quality Control testing.

The affected products were distributed nationwide. Specific lot codes for Phase 1 and Phase 2 are listed in the official recall documentation. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
Manufacturer: Alere San Diego, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
Affected units: 6,044

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 (20)

Phase 1: K50514B
W49753B
W49754B
W49756B
W49757B
W49758B
W49760B
W49761B
W49762B
W49764B
W49767B
W49768B
W49769B
W49770B
W50608B
W50613B
W50621B
W50623B
W50625B
W50632B

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.

See all →

Moderate
Alere hCG Urine Test Strips Recalled for False Positive Risk
FDA (Devices) · 2026-10-07
High
Alere hCG Pregnancy Test Cassettes Recalled for False Positive Results
FDA (Devices) · 2026-10-07
Moderate
Alere Recalls hCG Pregnancy Tests Due to False Positive Risk
FDA (Devices) · 2026-10-07
High
Alere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
High
Abbott Cholestech LDX Battery Kit Recall: Potential Swelling Risk
FDA (Devices) · 2024-05-08

Same hazard · inaccurate results