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Recall Observatory FDA recall evidence

Current FDA corpus

Search recall evidence

Search official identifiers, recalled products, recalling firms, recall reasons, distribution language, and available device root-cause evidence.

Ordinary terms are combined with AND. Put a literal phrase in quotation marks. Raw operators, wildcards, field syntax, and repeated controls are rejected.

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Results for “nationwide distribution”

35,881 true results · 25 per page

Events
8,763
Products
24,938
Firms
2,180

Events

8,763 true total · 9 on this page

Recall event

Event 83895

83895
Matched distribution pattern

Distribution pattern · Distribution was nationwide. There was government distribution, but no military distribution. Foreign distribution was made to Canada, Chile …

Represented date
August 22, 2019
Product type
Device
Classification
Class I
Matching products
1

Recall event

Event 95407

95407
Matched distribution pattern

Distribution pattern · Distribution was made nationwide to the U.S., including Puerto Rico. There was government distribution but no military …

Represented date
September 05, 2024
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 90511

90511
Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA …

Represented date
June 24, 2022
Product type
Device
Classification
Class II
Matching products
7

Recall event

Event 76509

76509
Matched code information

Code information · All units in distribution

Represented date
February 20, 2017
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 62768

62768
Matched product description

Product description · … and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards …

Represented date
March 15, 2012
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 76844

76844
Matched distribution pattern

Distribution pattern · Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries …

Represented date
April 04, 2016
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 75239

75239
Matched distribution pattern

Distribution pattern · Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.

Represented date
January 30, 2016
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 74243

74243
Matched distribution pattern

Distribution pattern · U.S. distributionnationwide. No foreign distribution.

Represented date
May 23, 2016
Product type
Food
Classification
Class I
Matching products
39

Recall event

Event 81837

81837
Matched distribution pattern

Distribution pattern · Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium …

Represented date
February 02, 2018
Product type
Device
Classification
Class II
Matching products
7

Products

24,938 true total · 13 on this page

Z-0265-2025
Matched distribution pattern

Distribution pattern · Distribution was made nationwide to the U.S., including Puerto Rico. There was government distribution but no military …

Represented date
September 05, 2024
Product type
Device
Classification
Class II
Z-2210-2019
Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution, including Puerto Rico. There was government and foreign distribution and no military distribution …

Represented date
May 02, 2019
Product type
Device
Classification
Class II

Recalled product

Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients, specimens, and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide.

Z-2332-2012
Matched product description

Product description · … and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards …

Represented date
March 15, 2012
Product type
Device
Classification
Class II
Z-2209-2019
Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution, including Puerto Rico. There was government and foreign distribution and no military distribution …

Represented date
May 02, 2019
Product type
Device
Classification
Class II
Z-1334-2019
Matched distribution pattern

Distribution pattern · Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium …

Represented date
February 02, 2018
Product type
Device
Classification
Class II

Firms

2,180 true total · 3 on this page

signal medical corporation
Matched code information

Code information · All units in distribution

Represented date
February 20, 2017
Product type
Device
Classification
Class II
Matching products
2
sunquest information systems inc
Matched product description

Product description · … and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards …

Represented date
March 15, 2012
Product type
Device
Classification
Class II
Matching products
9
let s do lunch inc
Matched distribution pattern

Distribution pattern · U.S. distributionnationwide. No foreign distribution.

Represented date
May 23, 2016
Product type
Food
Classification
Class I
Matching products
39

Field note

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