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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66209

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

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Event summary

Timeline bucket
September 06, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Horiba Instruments, Inc dba Horiba Medical

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.

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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

ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.

Z-2280-2013
Recall number
Z-2280-2013
Initiated
September 06, 2013
Classification
Class III
Status
Terminated
Quantity
2,658 units ( 1240 US 1418 OUS )

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.

Code information

Lot/Serial #(s): 014664503

Distribution pattern

Worldwide Distribution - USA including the country of Canada.