CLASS II Device recall · Reported 6 May 2015 · FDA Enforcement Report

CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product recalled

Biocare Medical is recalling CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product, distributed nationwide in the US. The recall was initiated on 17 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.

Quantity recalled44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1535-2015
FDA event ID: 70823
Recalling firm: Biocare Medical, Concord, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Mar 2015
FDA classified: 27 Apr 2015
Reported: 6 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

17 Mar 2015	Recall initiated by company
27 Apr 2015	Classified by FDA	+41 days
6 May 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.

Where it was distributed

Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.

Nationwide Georgia Kansas Louisiana North Carolina New Jersey Oklahoma South Carolina Texas Virginia

Questions about this recall

Why was it recalled?

A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.

Which lots are affected?

Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.

Where was it sold?

Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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