HemoCue¿ Hb 201 Microcuvettes — Class II medical device recall Z-0101-2014
Terminated recall by HemoCue AB, reported 2013-11-06, distributed in AK, AL, AS, AZ, CA, CO, CT, FL…. HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes s
| Recall number | Z-0101-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HemoCue AB, Angelholm, N/A, Sweden |
| Recall initiated | 2013-07-25 |
| Classified | 2013-10-29 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2014-08-11 |
| Distributed | 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, VT, WA, WI, WV, WY |
| Countries outside the US | AT, AU, BE, CH, CY, CZ, DE, DK, FI, FR, GB, GT, HK, IL, NL, NO, NZ, PE, PL, RU, SE, SV, TW, ZA |
| Lot numbers | 1208655, 1208657, 1208658, 1208659, 1208660, 1208661, 1208662, 1208663, 1208664, 1208665, 1209666, 1209667, 1209668, 1209669, 1209670, 1209671, 1209672, 1209673, 1209674, 1209675, 1209676, 1209677, 1209678, 1210679, 1210680, 1210681, 1210682, 1210683, 1210684, 1210685, 1210686, 1210687, 1210688, 1210689, 1211690, 1211691, 1211692, 1211693, 1211694, 1211695 and 38 more |
| Model numbers | 111715, 111717, 111722, 116101 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0101-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.