Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65854

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 15, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
HemoCue AB

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2190-2013
Recall number
Z-2190-2013
Initiated
July 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
HemoCue AB
Quantity
22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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; 1303518; 1303522-1303524; 1303785-1303787; 1303794; 1303796; 1303797 & 1304534-1304537. Model #, 110717, Lot #, 1208503; 1208785; 1208786; 1208789; 1208790; 1208796; 1208797; 1208798; 1209504 - 1209510; 1209518-1209521; 209526; 1209533; 1209534; 1209537; 1209541; 1210552; 1210553; 1210559; 1210561; 1210569; 1210575-1210579; 1210584-1210586; 1210589; 1210600; 1211598; 1211601; 1211606; 1211609; 1211610; 1211617; 1211619; 1211620; 1211628-1211630; 1211639-1211642; 1212650-1212652; 1212671-1212673; 1212681-1212685; 1212696; 1212698; 1212699; 1301709-1301711; 1301716-1301719; 1301722; 1301726-1301729; 1301732; 1302754-1302756; 1302766; 1302767; 1302771-1302773; 1302778-1302781; 1303500-1303502; 1303509-1303513; 1303519-1303521; 1303782; 1303788-1303792; 1303798; 1303799; 1304526- 1304531 & 1304542-1304544. Model #, 110718, Lot #, 1208502; 1208782-1208784; 1208792; 1208793; 1208799; 1209511; 1209512; 1209522; 1209523; 1209532; 1209535; 1209536; 1209538; 1209542; 1209544; 1209545; 1210554; 1210555; 1210562-1210568; 1210580; 1210592-1210596; 1211607; 1211612; 1211622; 1211631-1211633; 1211643-1211645; 1212653; 1212674; 1212675; 1212686; 1212700; 1212701; 1301706; 1301708; 1301714; 1301715; 1301720; 1301721; 1301730; 1301731; 1302759; 1302760; 1302764; 1302765; 1302774; 1303503; 1303514-1303516; 1303525; 1303783; 1303784; 1303793; 1304532; 1304533 & 1304539-1304541. Model #, 110721, Lot #, 1210555

Distribution pattern

Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIAN FEDERATION, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, VIET NAM & YEMEN. .