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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61927

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 22, 2012
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Alere San Diego, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.

Z-1928-2012
Recall number
Z-1928-2012
Initiated
May 22, 2012
Classification
Class I
Status
Terminated
Recalling firm
Alere San Diego, Inc.
Quantity
16,962 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

Code information

Phase 1: W49604B, W49606B, W49607B, W49611B, W49612B, W49613B, W49614B, W49615B, W49616B, W49617B, W49620B, W49622B, W49623B, W49624B, W49625B, W49627B, W49628B, W49629B, W49630B, W49631B, W49633B, W49634B, W49635B, W49638B, W49639B, W50726B, W50727B, W50728B, W50731B, W50733B, W50734B, W50738B, and W50739B. Phase 2: W49609B, W49610B, W49618B, W49619B, W49626B, W49632B, W49640B, W50737B, and W50744B.

Distribution pattern

Nationwide Distribution

device · product 2 of 5

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.

Z-1929-2012
Recall number
Z-1929-2012
Initiated
May 22, 2012
Classification
Class I
Status
Terminated
Recalling firm
Alere San Diego, Inc.
Quantity
6,044 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

Code information

Phase 1: K50514B, W49753B, W49754B, W49756B, W49757B, W49758B, W49760B, W49761B, W49762B, W49764B, W49767B, W49768B, W49769B, W49770B, W50608B, W50613B, W50621B, W50623B, W50625B, W50632B, W50634B, W50637B, W50639B, W50641B, W50642B, W51114B, and W51119B. Phase 2: W49766B, W50605B, W50627B, W50628B, and W50629B.

Distribution pattern

Nationwide Distribution

device · product 3 of 5

Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.

Z-1930-2012
Recall number
Z-1930-2012
Initiated
May 22, 2012
Classification
Class I
Status
Terminated
Recalling firm
Alere San Diego, Inc.
Quantity
5,013 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

Code information

Phase 1: K50708B, W50009B, W50011B, W50012B, W50013B, W50014B, W50016VB, W50021B, W50026B, W50028B, W50030B, W50771B, W50772B, W50773B, W50774B, W50778B, and W50801B. Phase 2: W50015B, W50029B, and W50788B.

Distribution pattern

Nationwide Distribution

device · product 4 of 5

Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).

Z-1931-2012
Recall number
Z-1931-2012
Initiated
May 22, 2012
Classification
Class I
Status
Terminated
Recalling firm
Alere San Diego, Inc.
Quantity
30,083 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

Code information

Phase 1: K50671B, W49486B, W49487B, W49489B, W49498B, W49500B, W49873B, W49890B, W49895B, W49896B, W49934B, W49947B, W49948B, W49950B, W49962B, W49968B, W50257B, W50278B, W50279B, W50282B, W50287B, W50294B, and W50313B. Phase 2: K50665B, W49855B, W49862B, W49865B, W49887B, W49892B, W49893B, W49894B, W49900B, W49933B, W49939B, W49953B, W49958B, W49960B, W49961B, W50252B, W50268B, W50273B, W50274B, W50290B, W50292B, W50295B, W50297B, W50298B, W50304B, W50355B, W50357B, and W50375B.

Distribution pattern

Nationwide Distribution

device · product 5 of 5

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.

Z-1932-2012
Recall number
Z-1932-2012
Initiated
May 22, 2012
Classification
Class I
Status
Terminated
Recalling firm
Alere San Diego, Inc.
Quantity
1,972 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 negative results are unpredictable within lots and may not be detected by Quality Control testing.

Code information

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

Distribution pattern

Nationwide Distribution