Reported Sep 18, 2013 · Terminated

HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are…

HemoCue AB

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: HemoCue AB · Kuvettgaten 1 · Angelholm, N/A · N/A

Is this the product you have?

  • HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
Lot codes and dates
  • 184 of 184 codes

    • Model #
    • 110705
    • Lot #
    • 1207767
    • 1208500
    • 1208501
    • 1208772
    • 1208773
    • 1208775
    • 1208777-1208781
    • 1208787
    • 1208788
    • 1208794
    • 1208795
    • 1209513-1209517
    • 1209527-1209531
    • 1209539
    • 1209540
    • 1209546
    • 1209547
    • 1210550
    • 1210551
    • 1210556-1210558
    • 1210560
    • 1210570-1210574
    • 1210581-1210583
    • 1210587
    • 1210590
    • 1210591
    • 1211599
    • 1211602-1211605
    • 1211608
    • 1211611
    • 1211614
    • 1211616
    • 1211618
    • 1211621
    • 1211623
    • 1211626
    • 1211627
    • 1211635
    • 1211636
    • 1211646-1212649
    • 1212654
    • 1212655
    • 1212659
    • 1212676-1212680
    • 1212687-1212689
    • 1212691-1212695
    • 1301702-1301705
    • 1301712
    • 1301713
    • 1301723-1301725
    • 1301733-1301735
    • 1302761-1302763
    • 1302768
    • 1302776
    • 1302777
    • 1303504-1303508
    • 1303517
Amount recalled
22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US

Where it was sold

  • Nationwide
  • GA

Why it was recalled

During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 2, 2014 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.