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HYALURONIDASE

INVITROCARE, INCORPORATED · Model 2212 · UDI-DI 00859268006145

510(k) clearances

Adverse events

Recalls

Facilities

Description

InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system at a concentration of 100units/ml and is appropriate for those procedures that do not use a carbon dioxide atmosphere. HYALURONIDASE reagent is intended for use prior to intracytoplasmic sperm injection (ICSI) procedures to digest the Hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.

Recalls

Date	Firm	Reason
2024-02-16	CooperSurgical, Inc.	Low concentration of sodium pyruvate in the wash could compromise gamete development
2024-02-16	CooperSurgical, Inc.	Low concentration of sodium pyruvate in the wash could compromise gamete development
2024-02-16	CooperSurgical, Inc.	Low concentration of sodium pyruvate in the wash could compromise gamete development
2023-12-20	CooperSurgical, Inc.	The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
2023-11-02	Fujifilm Irvine Scientific, Inc.	The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) b
2023-02-13	CooperSurgical, Inc.	It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source
2023-01-16	Fujifilm Irvine Scientific, Inc.	Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
2022-12-15	CooperSurgical, Inc.	The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
2022-06-13	CooperSurgical, Inc.	There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct
2021-09-08	Fujifilm Irvine Scientific, Inc.	Due to a component in kit being labeled with the incorrect Expiration Date

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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.