—#120341

Product

Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.

FDA product code: KHE — Reagent, Occult Blood
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K080812
Affected lot / code info: Part Number 395067. All In-date lots (42 lots total). Lot Number: Manuf. Date: Exp. Date: M207143 27Jul2012 01/31/2014 M208454 21Sep2012 02/28/2014 M210079 19Oct2012 03/31/2014 M211100 30Nov2012 05/31/2014 M212122 20Dec2012 06/30/2014 M212203 17Jan2013 06/30/2014 M301418 22Feb2013 & 28Feb2013 07/31/2014 M202086 24Feb2012 07/31/2013 M203081 16Mar2012 07/31/2013 M203081A 23Mar2012 07/31/2013 M203262 06Apr2012 08/31/2013 M203098 13Apr2012 08/31/2013 M203098A 20Apr2012 08/31/2013 M203098B 25Apr2012 08/31/2013 M203080 27Apr2012 10/31/2013 M203080A 04May2012 10/31/2013 M203080B 11May2012 10/31/2013 M204276 18May2012 09/30/2013 M205199 12May2012 09/30/2013 M205288 22May2012 11/30/2013 M206021 06June2012 11/30/2013 M206166 18June2012 12/31/2013 M207072 05July2012 12/31/2013 M207143 27July2012 01/31/2014 M206259 26June2012 12/31/2013 M207332 30July2012 01/31/2014 M208345 22Aug2012 01/31/2014 M208272 24Aug2012 02/28/2014 M208454 06Sep2012 02/28/2014 M209135 19Sep2012 03/31/2014 M210079 04Oct2012 03/31/2014 M210169 27Oct2012 04/30/2014 M211100 10Nov2012 05/31/2014 M211078 01Dec2012 05/31/2014 M212122 12Dec2012 06/30/2014 M212203 03Jan2013 06/30/2014 M301324 16Jan2013 07/31/2014 M301418 11Feb2013 07/31/2014 M302410 27Feb2013 08/31/2014 M303157 15Mar2013 09/30/2014 M303223 26Mar2013 09/30/2014 M304130 09Apr2013 09/30/2014

Why it was recalled

Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confirmed an increase in sensitivity at the borderline positive level. " This testing also demonstrated that the issue does not affect results reported as negative.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Beckman Coulter sent an Urgent Product Correction letter dated July 9, 2013, to all affected customers. The letter was accompanied with a cover letter and response form, dated July 9, 2013. Customers were informed of the product under recall with product description, actions to take, contact information, the issue, impact, and resolution. Beckman Coulter conducted a risk assessment for this issue. Per the risk documentation, there is only a remote probability that use of the product will cause any adverse health consequences,and the product is not likely to lead to serious adverse health consequences. If you have any questions please call (714) 961-3777.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution - USA and the country of Canada.

Timeline

Recall initiated: 2013-07-17
Posted by FDA: 2013-08-22
Terminated: 2014-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.