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FDA · Medical device recall

QIAcube Connect MDx…

Recall started · FDA enforcement report Sept. 21, 2022 Class II

Reason
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under…
Status
Ongoing
Distribution
Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.

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Enforcement report date
Sept. 21, 2022
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
Qiagen Sciences LLC
Product
QIAcube Connect MDx, Model No. 9003070
Reason
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
Distribution pattern
Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.
Quantity
93 US; 57 OUS
Codes and lots
UDI-DI (GTIN): 04053228039129 Serial Numbers (U.S.) 30000 30009 30027 30039 30049 30061 30073 30002 30010 30028 30041 30050 30062 30075 30003 30132 30031 30042 30051 30063 30078 30004 30013 30032 30043 30053 30064 30080 30005 30016 30034 30044 30057 30065 30082 30006 30019 30035 30045 30058 30067 30089 30007 30021 30033 30046 30059 30069 30090 30008 30023 30037 30047 30060 30071 30093 30094 30095 30097 30102 30104 30109 30112 30114 30115 30117 30118 30119 30121 30124 30127 30128 30129 30130 30131 30133 30134 30136 30138 30139 30140 30141 30143 30145 30106 30025 30077 30054 30055 30066 30076
Recall started
Nov. 21, 2021
Voluntary or mandated
Voluntary: Firm initiated
Device type
Clinical Sample Concentrator
Root cause (FDA)
Other
What the company told customers
Customers were notified of the initial issue by email beginning Nov 3 2021, and requested to return acknowledgment of the notice. On January 26, 2022, a new version of the protocol software was released and customers were advised of the new protocol availability and acknowledge download via a follow up notice.
Recall number
Z-1746-2022

What this record is about

A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.

A generic icon of the kind of thing the record is aboutA simplified icon of the kind of thing the record is about and the phrases of the record's own text beside it.1 The record: QIAcube Connect MDx, Model No. 90030702 In the record's words:3 Only the kind of thing is drawn4 The record's own words are below“Misunderstanding the guidance may lead to over diluted, underdiluted, or improperly lysed sample, which in turn could lead to…”QIACUBE CONNECT MDX…

“During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.”QIAcube Connect MDx, Model No. 9003070, FDA enforcement report, 2022-09-21. The caption is the record's own words.

The picture shows the kind of thing the record is about (a part, a product, a package), not the product itself; the ring marks it. Nothing in it is a claim beyond the record's own words below.

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FDA device name: Clinical Sample Concentrator

Distributed in (FDA's record): Arizona California Colorado Delaware District of Columbia Florida Georgia Iowa Kansas Louisiana Maryland Massachusetts Minnesota Nevada New Jersey New York North Carolina Ohio Pennsylvania South Carolina South Dakota Tennessee Texas Virginia Washington Wisconsin

This recall among the others

  • FDA's enforcement report came 304 days after the firm started the recall. For half of the 888 FDA medical device recall events reported in 2022 with a start date, it took 54 days or fewer (by year).
  • Qiagen Sciences: 9 other recalls or notices on this site in the three years before this one (from Sept. 22, 2019).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-1746-2022. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-1746-2022, Sept. 21, 2022. "QIAcube Connect MDx." PlainRecords, https://plainrecords.com/recall/device/z-1746-2022/ (as of the day it was built).

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