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STANDARD™ LipidoCare Analyzer

SD Biosensor, Inc. · Model 02LA10G · UDI-DI 00887473000320

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1
510(k) clearances
105
Adverse events
23
Recalls
82
Facilities

Recalls

DateFirmReason
2026-04-02DFI Co., Ltd.The devices were distributed without required FDA premarket clearance or approval.
2022-06-22Randox Laboratories Ltd.Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower t
2021-11-10Beckman Coulter Inc.Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calib
2021-11-01Randox Laboratories Ltd.When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
2019-06-07Polymer Technology Systems, Inc.The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
2019-06-07Polymer Technology Systems, Inc.The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
2019-01-16Polymer Technology Systems, Inc.Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) C
2019-01-16Polymer Technology Systems, Inc.Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed.
2017-04-03Beckman Coulter Inc.Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results
2016-07-20Sterling Diagnostics, Inc.Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.