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Open, Classified

ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

FDA Recall Z-1949-2019 · Posted None

Recalling FirmHelena Laboratories, Corp.
Recall StatusOpen, Classified
Product CodeKHE
Date Initiated2018-08-08
Product Quantity27/250 pouch kits

Reason for Recall

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

Firm Action

The recalling firm made notifications beginning 8/8/2018 via phone and letter delivered via email. Customers were to dispose of the product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution was made to AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WY. There was no foreign/military/government distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K882799HELENA COLOCAREHelena Laboratories · 1988-09-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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