Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a

FDA device recall Z-1344-2013 · posted 2013-05-21 · Terminated

Recall details

Recalling firm

Alere San Diego, Inc.

Reason for recall

Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.

Action taken

The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 21, 2013 to all their customers. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of the product; immediately discard all units of the the product in accordance with your local regulations; share this information with your laboratory staff and retain this letter for your records; if you have forwarded the product to another laboratory, provide a copy of this letter to them and include the name, address and a contact for the laboratory on the enclosed Customer Verification Form; complete and return the Customer Verification Form within 10 days via fax to: Technical Service at 858-805-8457 or e-mail to responses.ts@alere.com. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at lateral.flow.support@alere.com.

Root cause

Labeling mix-ups

Status

Terminated

Product code

JHI

Quantity affected

2,167 kits

Distribution

Nationwide distribution: USA including states of: AL, AK, AR, AZ, CA, CO, CT, DE, HI, IA, ID, IL, IN, FL, GA, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA

Date initiated

2013-01-21

Date posted

2013-05-21

Date terminated

2013-08-28

Location

San Diego, CA

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