Recall Z-0101-2014— HemoCue AB

Name: FDA recall Z-0101-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-25

Class II · Terminated

Class II FDA medical device recall by HemoCue AB, initiated 2013-07-25, terminated 2014-08-11. It names one FDA 510(k) clearance: K032203. Product: HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden. Reason: HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches..

Recalling firm: HemoCue AB
Classification: Class II
Status: Terminated
Initiated: 2013-07-25
Terminated: 2014-08-11
Firm location: Angelholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K032203 — HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704Hemocue, Inc.·cleared 2003-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden

Reason for recall

HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.

Data sourced from openFDA. This site is unofficial and independent of the FDA.