Class II — HemoCue AB
| Recalling firm | HemoCue AB |
|---|---|
| Registered facility | HEMOCUE AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. |
| Product | HemoCue® Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden |
| Quantity | 42,330 packages/4 boxes/25 microcuvetes |
| Distribution | Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY and the countries of Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Co… |
| Initiated | 2013-07-25 |
| Classified | 2013-10-29 |
| Terminated | 2014-08-11 |
| Recall number | Z-0101-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — HemoCue AB (Z-0101-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65920/
Alerts for HemoCue AB
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.